The present invention relates to a method for producing an analytical magazine which is designed to receive a plurality of analytical aids. The invention furthermore relates to an analytical magazine. Analytical magazines of this type are used in medical diagnostics, in particular, in order to qualitatively or quantitatively detect one or more analytes in body fluids. By way of example, said analytes can be metabolites, for example blood glucose.
In the field of diagnostics it is necessary in many cases to obtain samples of body fluid, in particular blood samples or samples of interstitial fluid, in order to be able to detect constituents therein, in particular specific analytes. Examples of such analytes are blood glucose, coagulation parameters, triglycerides, lactate or the like. In accordance with the detected concentrations, a decision can then be taken about a corresponding treatment, for example.
In the diagnostic methods mentioned, generally one or a plurality of analytical aids are used in order to obtain and/or analyze the samples of body fluid. Thus, the analytical aids can comprise lancets, for example, that is to say elements which are designed to produce an opening in a subject's skin, through which the body fluid can be drawn. As an example of such lancets, reference may be made to WO 02/36010 A1 (see also, US 2004/0034318).
Furthermore, the analytical aids can comprise one or a plurality of test elements with test chemicals which are designed to change specific detectable properties under the action of the analyte to be detected. By way of example, said analytes may comprise electrochemically detectable properties or the changes thereof and/or optically detectable properties. For such test chemicals, too, reference may be made to the prior art, for example J. Hones et al., Diabetes Technology & Therapeutics, Volume 10, Supplement 1, 2008, page 10 to page 26.
In addition, integrated test elements are also known which are used both for the purpose of producing a sample of body fluid and for the purpose of transporting the sample and, if appropriate, even for the purpose of qualitative and/or quantitative analysis of said sample. Examples of such analytical aids are so-called microsamplers, in which, by means of a lancet, a puncture or incision is produced, the sample is taken and is transported to one or a plurality of test fields with the test chemical. Said test fields can be arranged separately from the lancet, but can also be part of the lancet itself. Systems of this type, which are described for example in US 2004/0193202 A1, US 2008/0249435 A1 or in WO 03/009759 A1 (see also U.S. Pat. No. 7,288,073), are particularly user-friendly owing to their high degree of integration.
One technical challenge in providing analytical systems and analytical aids, however, consists in providing them in large quantities under suitable conditions. Thus, they generally have to be provided in such a way that the analytical aids are stored under sterile conditions, for example by means of corresponding seals. At the same time, however, the seals must not impair the quality of the analytical aids and must not make it more difficult to use said analytical aids. For this purpose, the analytical aids are generally provided by means of corresponding magazines, which are also referred to hereinafter as analytical magazines. For systems which are intended to carry out for example a capillary blood analysis fully automatically without the subject's intervention, a multiplicity of lancets and also a multiplicity of test elements, for example each with one or more test chemicals, may be present for example in a magazine of this type.
A multiplicity of different analytical magazines are known from the prior art. In principle, it is possible, independently of the type of analytical aid, to distinguish between three main types of magazines, namely round magazines (for example in the form of drums and/or disks), linear magazines (for example in the form of stack magazines, zigzag magazines or the like) and tape magazines, in which the analytical aids are arranged on a tape or some other form of at least partly flexible carrier. These types of magazines can, in principle, also be used, or modified, in the context of the invention described below. In the prior art, round magazines are described for example in US 2006/0008389, US 2007/0292314, US 2006/0184064, US 2003/0212347 or US 2002/0087056. Linear magazines are described for example in U.S. Pat. No. 6,036,924 or US 2003/0191415. Tape magazines are described for example in US 2002/0188224, in US 2008/0103415, in EP 1360935 A1 or in DE 19819407 A1.
Generally, the disadvantage in the case of analytical magazines, in particular integrated analytical magazines with combined analytical aids with lancet function and test element function, consists in ensuring freedom from contamination and sterility. By way of example, one difficulty is that each set composed of lancet and test element has to be kept separate from the respective other sets since at least the lancets have to be kept sterile until immediately before they are used.
However, these requirements in turn increase the outlay for the production of the analytical magazines. Owing to the different natures of lancets and test elements, the history of origination thereof is extremely different. Consequently, these elements of the system are generally provided in different forms of presentation for the assembly of the overall analytical magazine. These requirements mean that in practice analytical magazines generally have to be filled individually. Thus, by way of example, the lancets and the test elements have to be inserted individually into the analytical magazines and/or into individual chambers of the analytical magazines, which generally requires a high outlay in respect of apparatus. One exception in this regard is constituted only by tape-based systems, in which the individual elements can firstly be applied individually to a carrier tape and, having been wound up onto said carrier tape, can then be introduced into a magazine. In any event, however, the individual analytical aids have to be applied piece by piece, which requires a considerable production outlay.